AMSTERDAM – Patients treated with a tumor necrosis factor inhibitor for any indication had their mortality rate cut by about one third, compared with the general population, in a combined analysis of safety findings from 78 trials that involved nearly 30,000 patients.

This first indication that treatment with a tumor necrosis factor inhibitor (TNFi) significantly cut overall mortality only became apparent because of the very large number of patients and patient-years of treatment analyzed, and is likely a real effect – not an artifact – that’s probably linked in part to the anti-inflammatory effect from treatment and its favorable impact on cardiovascular disease events, Gerd R. Burmester, MD, said at the European Congress of Rheumatology.

The cut in overall mortality might also partially result from a “healthy cohort effect,” in which patients enrolled in trials pay more attention to their diet and other aspects of a healthy lifestyle, compared with the general population. But Dr. Burmester cited the recent results from the CANTOS trial that showed treatment with the anti-inflammatory drug canakinumab (Ilaris) was linked with a significant 12% relative reduction in cardiovascular death, myocardial infarction, and stroke (New Engl J Med. 2017 Sept 21;377[12]:1119-31).

“It may be that the anticytokine effect of TNFi works the same way as canakinumab,” Dr. Burmester said in an interview.

The results also confirmed previous reports, based on trial data from fewer numbers of TNFi-treated patients, of low rates of serious infections and malignancies, said Dr. Burmester, professor and director of the department of rheumatology and clinical immunology at Charité Medical University in Berlin.

The data he presented came from both randomized trials and open-label studies of adalimumab (Humira) conducted in several countries worldwide through the end of 2016. The various studies enrolled a total of 29,987 patients treated with adalimumab for 56,951 patient-years who had any of 11 different diseases, including rheumatologic, gastrointestinal, and dermatologic diseases. The most common condition treated in the studies was rheumatoid arthritis (in 33 of the 78 studies), followed by psoriasis (13 studies), and Crohn’s disease (11 studies).

The studies included 9,363 patients treated for at least 2 years, and 4,003 patients treated for at least 5 years. The median duration of adalimumab exposure was 0.7 years and the maximum exposure was just over 12 years.

The overall rate of serious infections in treated patients was 3.7 per 100 patient-years. The most common serious infections were pneumonia, at a rate of 0.6 per 100 patient-years, followed by cellulitis, at a rate of 0.2 per 100 patient-years. Active tuberculosis infections also occurred at a rate of 0.2 per 100 patient-years. Malignancies occurred at a rate of 0.6 per 100 patient-years. These rates were similar to those reported by Dr. Burmester and his associates in 2013 using data from a small pool of patients – 23,458 – enrolled in 71 studies of adalimumab (Ann Rheum Dis. 2013 Apr;72[4]:517-24).

In the current study, Dr. Burmester and his coauthors analyzed the observed mortality rate of the adalimumab-treated patients against the mortality rates for the general populations in the various countries in which the studies were run, based on World Health Organization statistics for the period 1997-2006, and adjusted so that the age and sex of the comparison general populations matched the age and sex of the treated patients. This analysis showed an overall, statistically significant mortality reduction in patients receiving adalimumab of 35%, which was consistent in both the subgroups of men and women.

The observed mortality reduction linked with TNFi treatment is likely a class effect, Dr. Burmester said, although similar analyses have not been conducted using data from patients treated with other TNFis. So far, he has been unsuccessful in getting similar, large-scale trial data from manufacturers of other TNFis that he has approached, but Dr. Burmester said he hopes to eventually receive these data so that he can perform an even larger analysis.

The study was sponsored by AbbVie, the company that markets adalimumab (Humira). Dr. Burmester has been a consultant to and speaker on behalf of AbbVie, as well as for Bristol Myers Squibb, Merk, Pfizer, Roche, and UCB.

[email protected]

SOURCE: Burmester GR et al. Ann Rheum Dis. 2018;77(Suppl 2):165. Abstract OP0233.

AMSTERDAM – Patients treated with a tumor necrosis factor inhibitor for any indication had their mortality rate cut by about one third, compared with the general population, in a combined analysis of safety findings from 78 trials that involved nearly 30,000 patients.

This first indication that treatment with a tumor necrosis factor inhibitor (TNFi) significantly cut overall mortality only became apparent because of the very large number of patients and patient-years of treatment analyzed, and is likely a real effect – not an artifact – that’s probably linked in part to the anti-inflammatory effect from treatment and its favorable impact on cardiovascular disease events, Gerd R. Burmester, MD, said at the European Congress of Rheumatology.

The cut in overall mortality might also partially result from a “healthy cohort effect,” in which patients enrolled in trials pay more attention to their diet and other aspects of a healthy lifestyle, compared with the general population. But Dr. Burmester cited the recent results from the CANTOS trial that showed treatment with the anti-inflammatory drug canakinumab (Ilaris) was linked with a significant 12% relative reduction in cardiovascular death, myocardial infarction, and stroke (New Engl J Med. 2017 Sept 21;377[12]:1119-31).

“It may be that the anticytokine effect of TNFi works the same way as canakinumab,” Dr. Burmester said in an interview.

The results also confirmed previous reports, based on trial data from fewer numbers of TNFi-treated patients, of low rates of serious infections and malignancies, said Dr. Burmester, professor and director of the department of rheumatology and clinical immunology at Charité Medical University in Berlin.

The data he presented came from both randomized trials and open-label studies of adalimumab (Humira) conducted in several countries worldwide through the end of 2016. The various studies enrolled a total of 29,987 patients treated with adalimumab for 56,951 patient-years who had any of 11 different diseases, including rheumatologic, gastrointestinal, and dermatologic diseases. The most common condition treated in the studies was rheumatoid arthritis (in 33 of the 78 studies), followed by psoriasis (13 studies), and Crohn’s disease (11 studies).

The studies included 9,363 patients treated for at least 2 years, and 4,003 patients treated for at least 5 years. The median duration of adalimumab exposure was 0.7 years and the maximum exposure was just over 12 years.

The overall rate of serious infections in treated patients was 3.7 per 100 patient-years. The most common serious infections were pneumonia, at a rate of 0.6 per 100 patient-years, followed by cellulitis, at a rate of 0.2 per 100 patient-years. Active tuberculosis infections also occurred at a rate of 0.2 per 100 patient-years. Malignancies occurred at a rate of 0.6 per 100 patient-years. These rates were similar to those reported by Dr. Burmester and his associates in 2013 using data from a small pool of patients – 23,458 – enrolled in 71 studies of adalimumab (Ann Rheum Dis. 2013 Apr;72[4]:517-24).

In the current study, Dr. Burmester and his coauthors analyzed the observed mortality rate of the adalimumab-treated patients against the mortality rates for the general populations in the various countries in which the studies were run, based on World Health Organization statistics for the period 1997-2006, and adjusted so that the age and sex of the comparison general populations matched the age and sex of the treated patients. This analysis showed an overall, statistically significant mortality reduction in patients receiving adalimumab of 35%, which was consistent in both the subgroups of men and women.

The observed mortality reduction linked with TNFi treatment is likely a class effect, Dr. Burmester said, although similar analyses have not been conducted using data from patients treated with other TNFis. So far, he has been unsuccessful in getting similar, large-scale trial data from manufacturers of other TNFis that he has approached, but Dr. Burmester said he hopes to eventually receive these data so that he can perform an even larger analysis.

The study was sponsored by AbbVie, the company that markets adalimumab (Humira). Dr. Burmester has been a consultant to and speaker on behalf of AbbVie, as well as for Bristol Myers Squibb, Merk, Pfizer, Roche, and UCB.

[email protected]

SOURCE: Burmester GR et al. Ann Rheum Dis. 2018;77(Suppl 2):165. Abstract OP0233.

AMSTERDAM – Patients treated with a tumor necrosis factor inhibitor for any indication had their mortality rate cut by about one third, compared with the general population, in a combined analysis of safety findings from 78 trials that involved nearly 30,000 patients.

This first indication that treatment with a tumor necrosis factor inhibitor (TNFi) significantly cut overall mortality only became apparent because of the very large number of patients and patient-years of treatment analyzed, and is likely a real effect – not an artifact – that’s probably linked in part to the anti-inflammatory effect from treatment and its favorable impact on cardiovascular disease events, Gerd R. Burmester, MD, said at the European Congress of Rheumatology.

The cut in overall mortality might also partially result from a “healthy cohort effect,” in which patients enrolled in trials pay more attention to their diet and other aspects of a healthy lifestyle, compared with the general population. But Dr. Burmester cited the recent results from the CANTOS trial that showed treatment with the anti-inflammatory drug canakinumab (Ilaris) was linked with a significant 12% relative reduction in cardiovascular death, myocardial infarction, and stroke (New Engl J Med. 2017 Sept 21;377[12]:1119-31).

“It may be that the anticytokine effect of TNFi works the same way as canakinumab,” Dr. Burmester said in an interview.

The results also confirmed previous reports, based on trial data from fewer numbers of TNFi-treated patients, of low rates of serious infections and malignancies, said Dr. Burmester, professor and director of the department of rheumatology and clinical immunology at Charité Medical University in Berlin.

The data he presented came from both randomized trials and open-label studies of adalimumab (Humira) conducted in several countries worldwide through the end of 2016. The various studies enrolled a total of 29,987 patients treated with adalimumab for 56,951 patient-years who had any of 11 different diseases, including rheumatologic, gastrointestinal, and dermatologic diseases. The most common condition treated in the studies was rheumatoid arthritis (in 33 of the 78 studies), followed by psoriasis (13 studies), and Crohn’s disease (11 studies).

The studies included 9,363 patients treated for at least 2 years, and 4,003 patients treated for at least 5 years. The median duration of adalimumab exposure was 0.7 years and the maximum exposure was just over 12 years.

The overall rate of serious infections in treated patients was 3.7 per 100 patient-years. The most common serious infections were pneumonia, at a rate of 0.6 per 100 patient-years, followed by cellulitis, at a rate of 0.2 per 100 patient-years. Active tuberculosis infections also occurred at a rate of 0.2 per 100 patient-years. Malignancies occurred at a rate of 0.6 per 100 patient-years. These rates were similar to those reported by Dr. Burmester and his associates in 2013 using data from a small pool of patients – 23,458 – enrolled in 71 studies of adalimumab (Ann Rheum Dis. 2013 Apr;72[4]:517-24).

In the current study, Dr. Burmester and his coauthors analyzed the observed mortality rate of the adalimumab-treated patients against the mortality rates for the general populations in the various countries in which the studies were run, based on World Health Organization statistics for the period 1997-2006, and adjusted so that the age and sex of the comparison general populations matched the age and sex of the treated patients. This analysis showed an overall, statistically significant mortality reduction in patients receiving adalimumab of 35%, which was consistent in both the subgroups of men and women.

The observed mortality reduction linked with TNFi treatment is likely a class effect, Dr. Burmester said, although similar analyses have not been conducted using data from patients treated with other TNFis. So far, he has been unsuccessful in getting similar, large-scale trial data from manufacturers of other TNFis that he has approached, but Dr. Burmester said he hopes to eventually receive these data so that he can perform an even larger analysis.

The study was sponsored by AbbVie, the company that markets adalimumab (Humira). Dr. Burmester has been a consultant to and speaker on behalf of AbbVie, as well as for Bristol Myers Squibb, Merk, Pfizer, Roche, and UCB.

[email protected]

SOURCE: Burmester GR et al. Ann Rheum Dis. 2018;77(Suppl 2):165. Abstract OP0233.

SAN DIEGO – Reserve soldiers who have never been deployed are just as likely to have poor outcomes related to mental health and substance use as their peers who have been deployed, results from a novel survey suggest.

“We tend to focus on screening and intervention efforts for soldiers who have been deployed and who have experienced combat, but we should also focus our intervention and screening efforts on soldiers who have never been deployed,” lead study author Rachel A. Hoopsick, MPH, said in an interview at the annual meeting of the College on Problems of Drug Dependence. “Both are at risk for substance use and mental illness.”

Doug Brunk/MDedge News

Ms. Hoopsick reported results from 121 never-deployed, male soldiers who completed the survey at baseline and at a 1-year follow-up. Their mean age was 30 years, 76% were non-Hispanic white, and 84% had at least some college education. In addition, the soldiers had served a mean of 5.5 years, had a mean of 0.6 military friends in the social network, and had a mean marital satisfaction score of 114 out of 158 possible points.

On responses to the Non-Deployment Emotions Questionnaire, 65% of nondeployed soldiers felt guilt, 56% felt decreased value within his unit, 50% felt decreased camaraderie within his unit, and 50% felt decreased connectedness within his unit for having never been deployed. “We did anticipate that some of these soldiers were going to have poor outcomes related to their nondeployment emotions, but it was surprising to see how many of the soldiers did express having negative emotions related to having never been deployed,” Ms. Hoopsick said. After the researchers controlled for years of military service, the number of military friends in the soldier’s social network, and marital satisfaction, more negative nondeployment emotions were associated with a greater likelihood of alcohol problems (adjusted risk ratio, 1.06), frequent heavy drinking (ARR, 1.03), and current nonmedical use of prescription drugs (ARR, 1.21).

She acknowledged certain limitations of the study, including its cross-sectional nature. “It would be interesting to have additional longitudinal studies looking at their outcomes over time,” she said.

The National Institute on Drug Abuse provided funding to Ms. Hoopsick’s mentor and coauthor, Gregory G. Homish, PhD, and the study received additional funding from the National Center for Advancing Translational Sciences and the Health Resources and Services Administration.

[email protected]

SAN DIEGO – Reserve soldiers who have never been deployed are just as likely to have poor outcomes related to mental health and substance use as their peers who have been deployed, results from a novel survey suggest.

“We tend to focus on screening and intervention efforts for soldiers who have been deployed and who have experienced combat, but we should also focus our intervention and screening efforts on soldiers who have never been deployed,” lead study author Rachel A. Hoopsick, MPH, said in an interview at the annual meeting of the College on Problems of Drug Dependence. “Both are at risk for substance use and mental illness.”

Doug Brunk/MDedge News

Ms. Hoopsick reported results from 121 never-deployed, male soldiers who completed the survey at baseline and at a 1-year follow-up. Their mean age was 30 years, 76% were non-Hispanic white, and 84% had at least some college education. In addition, the soldiers had served a mean of 5.5 years, had a mean of 0.6 military friends in the social network, and had a mean marital satisfaction score of 114 out of 158 possible points.

On responses to the Non-Deployment Emotions Questionnaire, 65% of nondeployed soldiers felt guilt, 56% felt decreased value within his unit, 50% felt decreased camaraderie within his unit, and 50% felt decreased connectedness within his unit for having never been deployed. “We did anticipate that some of these soldiers were going to have poor outcomes related to their nondeployment emotions, but it was surprising to see how many of the soldiers did express having negative emotions related to having never been deployed,” Ms. Hoopsick said. After the researchers controlled for years of military service, the number of military friends in the soldier’s social network, and marital satisfaction, more negative nondeployment emotions were associated with a greater likelihood of alcohol problems (adjusted risk ratio, 1.06), frequent heavy drinking (ARR, 1.03), and current nonmedical use of prescription drugs (ARR, 1.21).

She acknowledged certain limitations of the study, including its cross-sectional nature. “It would be interesting to have additional longitudinal studies looking at their outcomes over time,” she said.

The National Institute on Drug Abuse provided funding to Ms. Hoopsick’s mentor and coauthor, Gregory G. Homish, PhD, and the study received additional funding from the National Center for Advancing Translational Sciences and the Health Resources and Services Administration.

[email protected]

SAN DIEGO – Reserve soldiers who have never been deployed are just as likely to have poor outcomes related to mental health and substance use as their peers who have been deployed, results from a novel survey suggest.

“We tend to focus on screening and intervention efforts for soldiers who have been deployed and who have experienced combat, but we should also focus our intervention and screening efforts on soldiers who have never been deployed,” lead study author Rachel A. Hoopsick, MPH, said in an interview at the annual meeting of the College on Problems of Drug Dependence. “Both are at risk for substance use and mental illness.”

Doug Brunk/MDedge News

Ms. Hoopsick reported results from 121 never-deployed, male soldiers who completed the survey at baseline and at a 1-year follow-up. Their mean age was 30 years, 76% were non-Hispanic white, and 84% had at least some college education. In addition, the soldiers had served a mean of 5.5 years, had a mean of 0.6 military friends in the social network, and had a mean marital satisfaction score of 114 out of 158 possible points.

On responses to the Non-Deployment Emotions Questionnaire, 65% of nondeployed soldiers felt guilt, 56% felt decreased value within his unit, 50% felt decreased camaraderie within his unit, and 50% felt decreased connectedness within his unit for having never been deployed. “We did anticipate that some of these soldiers were going to have poor outcomes related to their nondeployment emotions, but it was surprising to see how many of the soldiers did express having negative emotions related to having never been deployed,” Ms. Hoopsick said. After the researchers controlled for years of military service, the number of military friends in the soldier’s social network, and marital satisfaction, more negative nondeployment emotions were associated with a greater likelihood of alcohol problems (adjusted risk ratio, 1.06), frequent heavy drinking (ARR, 1.03), and current nonmedical use of prescription drugs (ARR, 1.21).

She acknowledged certain limitations of the study, including its cross-sectional nature. “It would be interesting to have additional longitudinal studies looking at their outcomes over time,” she said.

The National Institute on Drug Abuse provided funding to Ms. Hoopsick’s mentor and coauthor, Gregory G. Homish, PhD, and the study received additional funding from the National Center for Advancing Translational Sciences and the Health Resources and Services Administration.

[email protected]

The American College of Chest Physicians (CHEST) announces a new partnership with Medscape focused on supporting physicians in addressing the challenges of diagnosing and treating moderate to severe asthma. The Moderate to Severe Asthma Center of Excellence will provide news, expert commentary, and insights on challenging cases to physicians specializing in chest medicine, allergy, primary care, pediatrics, and emergency medicine.

Medscape is a leading source of clinical news, health information, and point-of-care tools for physicians and health-care professionals. This new Center of Excellence available on Medscape.com will explore the diagnostic, therapeutic, and prevention strategies associated with moderate to severe asthma, including the latest research and breakthroughs. Topics will include challenges in classifying and diagnosing disease; risks, benefits, and barriers to treatment; and impact on patients’ quality of life.

Don’t miss Dr. Aaron Holley’s video on “Diagnosing Severe Asthma: ‘Not as Easy as It Sounds’ ”

Visit the Moderate to Severe Asthma Center of Excellence at https://www.medscape.com/resource/moderate-severe-asthma

The American College of Chest Physicians (CHEST) announces a new partnership with Medscape focused on supporting physicians in addressing the challenges of diagnosing and treating moderate to severe asthma. The Moderate to Severe Asthma Center of Excellence will provide news, expert commentary, and insights on challenging cases to physicians specializing in chest medicine, allergy, primary care, pediatrics, and emergency medicine.

Medscape is a leading source of clinical news, health information, and point-of-care tools for physicians and health-care professionals. This new Center of Excellence available on Medscape.com will explore the diagnostic, therapeutic, and prevention strategies associated with moderate to severe asthma, including the latest research and breakthroughs. Topics will include challenges in classifying and diagnosing disease; risks, benefits, and barriers to treatment; and impact on patients’ quality of life.

Don’t miss Dr. Aaron Holley’s video on “Diagnosing Severe Asthma: ‘Not as Easy as It Sounds’ ”

Visit the Moderate to Severe Asthma Center of Excellence at https://www.medscape.com/resource/moderate-severe-asthma

The American College of Chest Physicians (CHEST) announces a new partnership with Medscape focused on supporting physicians in addressing the challenges of diagnosing and treating moderate to severe asthma. The Moderate to Severe Asthma Center of Excellence will provide news, expert commentary, and insights on challenging cases to physicians specializing in chest medicine, allergy, primary care, pediatrics, and emergency medicine.

Medscape is a leading source of clinical news, health information, and point-of-care tools for physicians and health-care professionals. This new Center of Excellence available on Medscape.com will explore the diagnostic, therapeutic, and prevention strategies associated with moderate to severe asthma, including the latest research and breakthroughs. Topics will include challenges in classifying and diagnosing disease; risks, benefits, and barriers to treatment; and impact on patients’ quality of life.

Don’t miss Dr. Aaron Holley’s video on “Diagnosing Severe Asthma: ‘Not as Easy as It Sounds’ ”

Visit the Moderate to Severe Asthma Center of Excellence at https://www.medscape.com/resource/moderate-severe-asthma

ORLANDO – An elevated circulating galactin-3 level after an acute MI is a potent long-term predictor of both heart failure and mortality, independent of known prognostic markers, Rabea Asleh, MD, PhD, reported at the annual meeting of the American College of Cardiology.

“These findings suggest that galectin-3 measurement may have a role in the risk stratification of patients presenting with MI,” according to Dr. Asleh, an Israeli cardiologist doing a fellowship in advanced heart failure and transplant cardiology at the Mayo Clinic in Rochester, Minn.

Bruce Jancin/MDedge News

[email protected]

ORLANDO – An elevated circulating galactin-3 level after an acute MI is a potent long-term predictor of both heart failure and mortality, independent of known prognostic markers, Rabea Asleh, MD, PhD, reported at the annual meeting of the American College of Cardiology.

“These findings suggest that galectin-3 measurement may have a role in the risk stratification of patients presenting with MI,” according to Dr. Asleh, an Israeli cardiologist doing a fellowship in advanced heart failure and transplant cardiology at the Mayo Clinic in Rochester, Minn.

Bruce Jancin/MDedge News

[email protected]

ORLANDO – An elevated circulating galactin-3 level after an acute MI is a potent long-term predictor of both heart failure and mortality, independent of known prognostic markers, Rabea Asleh, MD, PhD, reported at the annual meeting of the American College of Cardiology.

“These findings suggest that galectin-3 measurement may have a role in the risk stratification of patients presenting with MI,” according to Dr. Asleh, an Israeli cardiologist doing a fellowship in advanced heart failure and transplant cardiology at the Mayo Clinic in Rochester, Minn.

Bruce Jancin/MDedge News

[email protected]

ABSTRACT

Postoperative pain management is an important component of total shoulder arthroplasty (TSA). Continuous cryotherapy (CC) has been proposed as a means of improving postoperative pain control. However, CC represents an increased cost not typically covered by insurance. The purpose of this study is to compare CC to plain ice (ICE) following TSA. The hypothesis was that CC would lead to lower pain scores and decreased narcotic usage during the first 2 weeks postoperatively.

A randomized controlled trial was performed to compare CC to ICE. Forty patients were randomized to receive either CC or ICE following TSA. The rehabilitation and pain control protocols were otherwise standardized. Visual analog scales (VAS) for pain, satisfaction with cold therapy, and quality of sleep were recorded preoperatively and postoperatively at 24 hours, 3 days, 7 days, and 14 days following surgery. Narcotic usage in morphine equivalents was also recorded. 

No significant differences in preoperative pain (5.9 vs 6.8; P = .121), or postoperative pain at 24 hours (4.2 vs 4.3; P = .989), 3 days (4.8 vs 4.7; P = .944), 7 days (2.9 vs 3.3; P = .593) or 14 days (2.5 vs 2.7; P = .742) were observed between the CC and ICE groups. Similarly, no differences in quality of sleep, satisfaction with the cold therapy, or narcotic usage at any time interval were observed between the 2 groups.

No differences in pain control, quality of sleep, patient satisfaction, or narcotic usage were detected between CC and ICE following TSA. CC may offer convenience as an advantage, but the increased cost associated with this type of treatment may not be justified.

The number of total shoulder arthroplasties (TSAs) performed annually is increasing dramatically.¹ At the same time, there has been a push toward decreased length of hospital stay and earlier mobilization following joint replacement surgery. Central to these goals is adequate pain control. Multimodal pain pathways exist, and one of the safest and cheapest methods of pain control is cold therapy, which can be accomplished with continuous cryotherapy (CC) or plain ice (ICE).

Continue to: The mechanism of cryotherapy...

The knee literature contains multiple studies that have examined the benefits of cryotherapy after both arthroscopic and arthroplasty procedures. The clinical benefits on pain have been equivocal with some studies showing improvements using cryotherapy^3,4 and others showing no difference in the treatment group.^5,6

Few studies have examined cryotherapy for the shoulder. Speer and colleagues⁷ demonstrated that postoperative use of CC was effective in reducing recovery time after shoulder surgery. However; they did not provide an ICE comparative group and did not focus specifically on TSA. In another study, Kraeutler and colleagues⁸ examined only arthroscopic shoulder surgery cases in a randomized prospective trial and found no significant different between CC and ICE. They concluded that there did not appear to be a significant benefit in using CC over ICE for arthroscopic shoulder procedures.

The purpose of this study is to prospectively evaluate CC and ICE following TSA. The hypothesis was that CC leads to improved pain control, less narcotic consumption, and improved quality of sleep compared to ICE in the immediate postoperative period following TSA.

MATERIALS AND METHODS

This was a prospective randomized control study of patients undergoing TSA receiving either CC or ICE postoperatively. Institutional Review Board approval was obtained before commencement of the study. Inclusion criteria included patients aged 30 to 90 years old undergoing a primary or revision shoulder arthroplasty procedure between June 2015 and January 2016. Exclusion criteria included hemiarthroplasty procedures.

Continue to: Three patients refused...

Table 1. Summary of Surgical Cases

Abbreviations: CC, continuous cryotherapy; ICE, plain ice; RSA, reverse shoulder arthroplasty; TSA, total shoulder arthroplasty.

All surgeries were performed by Dr. Denard. All patients received a single-shot interscalene nerve block prior to the procedure. A deltopectoral approach was utilized, and the subscapularis was managed with the peel technique.⁹ All patients were admitted to the hospital following surgery. Standard postoperative pain control consisted of as-needed intravenous morphine (1-2 mg every 2 hours, as needed) or an oral narcotic (hydrocodone/acetaminophen 5/325mg, 1-2 every 4 hours, as needed) which was also provided at discharge. However, total narcotic usage was recorded in morphine equivalents to account for substitutions. No non-steroidal anti-inflammatory drugs were allowed until 3 months postoperatively. 

The CC group received treatment from a commercially available cryotherapy unit (Polar Care; Breg). All patients received instructions by a medical professional on how to use the unit. The unit was applied immediately postoperatively and set at a temperature of 45°F to 55°F. Patients were instructed to use the unit continuously during postoperative days 0 to 3. This cryotherapy was administered by a nurse while in the hospital but was left to the responsibility of the patient upon discharge. Patients were instructed to use the unit as needed for pain control during the day and continuously while asleep from days 4 to14. 

The ICE group used standard ice packs postoperatively. The patients were instructed to apply an ice pack for 20 min every 2 hours while awake during days 0 to 3. This therapy was administered by a nurse while in the hospital but left to the responsibility of the patient upon discharge. Patients were instructed to use ice packs as needed for pain control during the day at a maximum of 20 minutes per hour on postoperative days 4 to 14. Compliance by both groups was monitored using a patient survey after hospital discharge. The number of hours that patients used either the CC or ICE per 24-hour period was recorded at 24 hours, 3 days, 7 days, and 14 days. The nursing staff recorded the number of hours of use of either cold modality for each patient prior to hospital discharge. The average length of stay as an inpatient was 1.2 days for the CC group and 1.3 days for the ICE group. 

Visual analog scales (VAS) for pain, satisfaction with the cold therapy, and quality of sleep were recorded preoperatively and postoperatively at 24 hours, 3 days, 7 days, and 14 days following surgery. 

Continue to: The Wilcoxon rank-sum test...

STATISTICAL METHOD

The Wilcoxon rank-sum test was used to assess whether scores changed significantly from the preoperative period to the different postoperative time intervals, as well as to assess the values for pain, quality of sleep, and patient satisfaction. P-values <.05 were considered significant.

RESULTS

No differences were observed in the baseline characteristics between the 2 groups. Both groups showed improvements in pain, quality of sleep, and satisfaction with the cold therapy from the preoperative period to the final follow-up.

The VAS pain scores were not different between the CC and ICE groups preoperatively (5.9 vs 6.8; P = .121) or postoperatively at 24 hours (4.2 vs 4.3; P = .989), 3 days (4.8 vs 4.7; P = .944), 7 days (2.9 vs 3.3; P = .593), or 14 days (2.5 vs 2.7; P = .742).  Both cohorts demonstrated improved overall pain throughout the study period. These findings are summarized in Table 2. 

Table 2. Summary of VAS Pain Scores With Cold Therapy

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice; VAS, visual analog scales.

The number of morphine equivalents of pain medication was not different between the CC and ICE groups postoperatively at 24 hours (43 vs 38 mg; P = .579), 3 days (149 vs 116 mg; P = .201), 7 days (308 vs 228 mg; P = .181), or 14 days (431 vs 348 mg; P = .213). Both groups showed increased narcotic consumption from 24 hours postoperatively until the 2-week follow-up. Narcotic consumption is summarized in Table 3.

Table 3. Summary of Narcotic Consumption in Morphine Equivalents

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice.

VAS for quality of sleep improved in both groups from 24 hours postoperatively until the final follow-up. However, no significant differences in sleep quality were observed between the CC and ICE groups postoperatively at 24 hours (5.1 vs 4.3; P = .382), 3 days (5.1 vs 5.3; P = .601), 7 days (6.0 vs 6.7; P = .319), or 14 days (6.5 vs 7.1; P = .348). The VAS scores for sleep quality are reported in Table 4.

Table 4. Summary of VAS Sleep Quality With Cold Therapy^a

^a0-10 rating with 10 being the highest possible score.

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice; VAS, visual analog scales.

Continue to: Finally, VAS patient satisfaction...

While compliance within each group utilizing the randomly assigned cold modality was similar, the usage by the CC group was consistently higher at all time points recorded. No complications or reoperations were observed in either group.

DISCUSSION

The optimal method for managing postoperative pain from an arthroplasty procedure is controversial. This prospective randomized study attempted to confirm the hypothesis that CC infers better pain control, improves quality of sleep, and decreases narcotic usage compared to ICE in the first 2 weeks after a TSA procedure. The results of this study refuted our hypothesis, demonstrating no significant difference in pain control, satisfaction, narcotic usage, or sleep quality between the CC and ICE cohorts at all time points studied. 

Studies on knees and lower extremities demonstrate equivocal results for the role CC plays in providing improved postoperative pain control. Thienpont¹⁰ evaluated CC in a randomized control trial comparing plain ice packs postoperatively in patients who underwent TKA. The author found no significant difference in VAS for pain or narcotic consumption in morphine equivalents. Thienpont¹⁰ recommended that CC not be used for outpatient knee arthroplasty as it is an additional cost that does not improve pain significantly. Healy and colleagues⁵ reported similar results that CC did not demonstrate a difference in narcotic requirement or pain control compared to plain ice packs, as well as no difference in local postoperative swelling or wound drainage. However, a recently published randomized trial by Su and colleagues¹¹ comparing a cryopneumatic device and ICE with static compression in patients who underwent TKA demonstrated significantly lower narcotic consumption and increased ambulation distances in the treatment group. The treatment group consumed approximately 170 mg morphine equivalents less than the control group between discharge and the 2-week postoperative visit. In addition, a significant difference was observed in the satisfaction scores in the treatment group.¹¹ Similarly, a meta-analysis by Raynor and colleagues¹² on randomized clinical trials comparing cryotherapy to a placebo group after anterior cruciate ligament reconstruction showed that cryotherapy is associated with significantly lower postoperative pain (P = .02), but demonstrated no difference in postoperative drainage (P = .23) or range of motion (P = .25).

Although multiple studies have been published regarding the efficacy of cryotherapy after knee surgery, very few studies have compared CC to conventional ICE after shoulder surgery. A prospective randomized trial was performed by Singh and colleagues¹³ to compare CC vs no ICE in open and arthroscopic shoulder surgery patients. Both the open and arthroscopic groups receiving CC demonstrated significant reductions in pain frequency and more restful sleep at the 7-day, 14-day, and 21-day intervals compared to the control group. However, they did not compare the commercial unit to ICE. In contrast, a study by Kraeutler and colleagues⁸ randomized 46 patients to receive either CC or ICE in the setting of arthroscopic shoulder surgery. Although no significant difference was observed in morphine equivalent dosage between the 2 groups, the CC group used more pain medication on every postoperative day during the first week after surgery. They found no difference between the 2 groups with regards to narcotic consumption or pain scores. The results of this study mirror those by Kraeutler and colleagues,⁸ demonstrating no difference in pain scores, sleep quality, or narcotic consumption.

Continue to: With rising costs in the US...

The major strengths of this study are the randomized design and multiple data points during the early postoperative period. However, there are several limitations. First, we did not objectively measure compliance of either therapy and relied only on a patient survey. Usage of the commercial CC unit in hours decreased over half between days 3 and 14. This occurred despite training on the application and specific instructions. We believe this reflects “real-world” usage, but it is possible that compliance affected our results. Second, all patients in this study had a single-shot interscalene block. While this is standard at our institution, it is possible that either CC or ICE would have a more significant effect in the absence of an interscalene block. Finally, we did not evaluate final outcomes in this study and therefore cannot determine if the final outcome was different between the 2 groups. Our goal was simply to evaluate the first 2 weeks following surgery, as this is the most painful period following TSA. 

CONCLUSION

There was no difference between CC and ICE in terms of pain control, quality of sleep, patient satisfaction, or narcotic consumption following TSA. CC may offer convenience advantages, but the increased cost associated with this type of unit may not be justified. 

ABSTRACT

Postoperative pain management is an important component of total shoulder arthroplasty (TSA). Continuous cryotherapy (CC) has been proposed as a means of improving postoperative pain control. However, CC represents an increased cost not typically covered by insurance. The purpose of this study is to compare CC to plain ice (ICE) following TSA. The hypothesis was that CC would lead to lower pain scores and decreased narcotic usage during the first 2 weeks postoperatively.

A randomized controlled trial was performed to compare CC to ICE. Forty patients were randomized to receive either CC or ICE following TSA. The rehabilitation and pain control protocols were otherwise standardized. Visual analog scales (VAS) for pain, satisfaction with cold therapy, and quality of sleep were recorded preoperatively and postoperatively at 24 hours, 3 days, 7 days, and 14 days following surgery. Narcotic usage in morphine equivalents was also recorded. 

No significant differences in preoperative pain (5.9 vs 6.8; P = .121), or postoperative pain at 24 hours (4.2 vs 4.3; P = .989), 3 days (4.8 vs 4.7; P = .944), 7 days (2.9 vs 3.3; P = .593) or 14 days (2.5 vs 2.7; P = .742) were observed between the CC and ICE groups. Similarly, no differences in quality of sleep, satisfaction with the cold therapy, or narcotic usage at any time interval were observed between the 2 groups.

No differences in pain control, quality of sleep, patient satisfaction, or narcotic usage were detected between CC and ICE following TSA. CC may offer convenience as an advantage, but the increased cost associated with this type of treatment may not be justified.

The number of total shoulder arthroplasties (TSAs) performed annually is increasing dramatically.¹ At the same time, there has been a push toward decreased length of hospital stay and earlier mobilization following joint replacement surgery. Central to these goals is adequate pain control. Multimodal pain pathways exist, and one of the safest and cheapest methods of pain control is cold therapy, which can be accomplished with continuous cryotherapy (CC) or plain ice (ICE).

Continue to: The mechanism of cryotherapy...

The knee literature contains multiple studies that have examined the benefits of cryotherapy after both arthroscopic and arthroplasty procedures. The clinical benefits on pain have been equivocal with some studies showing improvements using cryotherapy^3,4 and others showing no difference in the treatment group.^5,6

Few studies have examined cryotherapy for the shoulder. Speer and colleagues⁷ demonstrated that postoperative use of CC was effective in reducing recovery time after shoulder surgery. However; they did not provide an ICE comparative group and did not focus specifically on TSA. In another study, Kraeutler and colleagues⁸ examined only arthroscopic shoulder surgery cases in a randomized prospective trial and found no significant different between CC and ICE. They concluded that there did not appear to be a significant benefit in using CC over ICE for arthroscopic shoulder procedures.

The purpose of this study is to prospectively evaluate CC and ICE following TSA. The hypothesis was that CC leads to improved pain control, less narcotic consumption, and improved quality of sleep compared to ICE in the immediate postoperative period following TSA.

MATERIALS AND METHODS

This was a prospective randomized control study of patients undergoing TSA receiving either CC or ICE postoperatively. Institutional Review Board approval was obtained before commencement of the study. Inclusion criteria included patients aged 30 to 90 years old undergoing a primary or revision shoulder arthroplasty procedure between June 2015 and January 2016. Exclusion criteria included hemiarthroplasty procedures.

Continue to: Three patients refused...

Table 1. Summary of Surgical Cases

Abbreviations: CC, continuous cryotherapy; ICE, plain ice; RSA, reverse shoulder arthroplasty; TSA, total shoulder arthroplasty.

All surgeries were performed by Dr. Denard. All patients received a single-shot interscalene nerve block prior to the procedure. A deltopectoral approach was utilized, and the subscapularis was managed with the peel technique.⁹ All patients were admitted to the hospital following surgery. Standard postoperative pain control consisted of as-needed intravenous morphine (1-2 mg every 2 hours, as needed) or an oral narcotic (hydrocodone/acetaminophen 5/325mg, 1-2 every 4 hours, as needed) which was also provided at discharge. However, total narcotic usage was recorded in morphine equivalents to account for substitutions. No non-steroidal anti-inflammatory drugs were allowed until 3 months postoperatively. 

The CC group received treatment from a commercially available cryotherapy unit (Polar Care; Breg). All patients received instructions by a medical professional on how to use the unit. The unit was applied immediately postoperatively and set at a temperature of 45°F to 55°F. Patients were instructed to use the unit continuously during postoperative days 0 to 3. This cryotherapy was administered by a nurse while in the hospital but was left to the responsibility of the patient upon discharge. Patients were instructed to use the unit as needed for pain control during the day and continuously while asleep from days 4 to14. 

The ICE group used standard ice packs postoperatively. The patients were instructed to apply an ice pack for 20 min every 2 hours while awake during days 0 to 3. This therapy was administered by a nurse while in the hospital but left to the responsibility of the patient upon discharge. Patients were instructed to use ice packs as needed for pain control during the day at a maximum of 20 minutes per hour on postoperative days 4 to 14. Compliance by both groups was monitored using a patient survey after hospital discharge. The number of hours that patients used either the CC or ICE per 24-hour period was recorded at 24 hours, 3 days, 7 days, and 14 days. The nursing staff recorded the number of hours of use of either cold modality for each patient prior to hospital discharge. The average length of stay as an inpatient was 1.2 days for the CC group and 1.3 days for the ICE group. 

Visual analog scales (VAS) for pain, satisfaction with the cold therapy, and quality of sleep were recorded preoperatively and postoperatively at 24 hours, 3 days, 7 days, and 14 days following surgery. 

Continue to: The Wilcoxon rank-sum test...

STATISTICAL METHOD

The Wilcoxon rank-sum test was used to assess whether scores changed significantly from the preoperative period to the different postoperative time intervals, as well as to assess the values for pain, quality of sleep, and patient satisfaction. P-values <.05 were considered significant.

RESULTS

No differences were observed in the baseline characteristics between the 2 groups. Both groups showed improvements in pain, quality of sleep, and satisfaction with the cold therapy from the preoperative period to the final follow-up.

The VAS pain scores were not different between the CC and ICE groups preoperatively (5.9 vs 6.8; P = .121) or postoperatively at 24 hours (4.2 vs 4.3; P = .989), 3 days (4.8 vs 4.7; P = .944), 7 days (2.9 vs 3.3; P = .593), or 14 days (2.5 vs 2.7; P = .742).  Both cohorts demonstrated improved overall pain throughout the study period. These findings are summarized in Table 2. 

Table 2. Summary of VAS Pain Scores With Cold Therapy

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice; VAS, visual analog scales.

The number of morphine equivalents of pain medication was not different between the CC and ICE groups postoperatively at 24 hours (43 vs 38 mg; P = .579), 3 days (149 vs 116 mg; P = .201), 7 days (308 vs 228 mg; P = .181), or 14 days (431 vs 348 mg; P = .213). Both groups showed increased narcotic consumption from 24 hours postoperatively until the 2-week follow-up. Narcotic consumption is summarized in Table 3.

Table 3. Summary of Narcotic Consumption in Morphine Equivalents

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice.

VAS for quality of sleep improved in both groups from 24 hours postoperatively until the final follow-up. However, no significant differences in sleep quality were observed between the CC and ICE groups postoperatively at 24 hours (5.1 vs 4.3; P = .382), 3 days (5.1 vs 5.3; P = .601), 7 days (6.0 vs 6.7; P = .319), or 14 days (6.5 vs 7.1; P = .348). The VAS scores for sleep quality are reported in Table 4.

Table 4. Summary of VAS Sleep Quality With Cold Therapy^a

^a0-10 rating with 10 being the highest possible score.

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice; VAS, visual analog scales.

Continue to: Finally, VAS patient satisfaction...

While compliance within each group utilizing the randomly assigned cold modality was similar, the usage by the CC group was consistently higher at all time points recorded. No complications or reoperations were observed in either group.

DISCUSSION

The optimal method for managing postoperative pain from an arthroplasty procedure is controversial. This prospective randomized study attempted to confirm the hypothesis that CC infers better pain control, improves quality of sleep, and decreases narcotic usage compared to ICE in the first 2 weeks after a TSA procedure. The results of this study refuted our hypothesis, demonstrating no significant difference in pain control, satisfaction, narcotic usage, or sleep quality between the CC and ICE cohorts at all time points studied. 

Studies on knees and lower extremities demonstrate equivocal results for the role CC plays in providing improved postoperative pain control. Thienpont¹⁰ evaluated CC in a randomized control trial comparing plain ice packs postoperatively in patients who underwent TKA. The author found no significant difference in VAS for pain or narcotic consumption in morphine equivalents. Thienpont¹⁰ recommended that CC not be used for outpatient knee arthroplasty as it is an additional cost that does not improve pain significantly. Healy and colleagues⁵ reported similar results that CC did not demonstrate a difference in narcotic requirement or pain control compared to plain ice packs, as well as no difference in local postoperative swelling or wound drainage. However, a recently published randomized trial by Su and colleagues¹¹ comparing a cryopneumatic device and ICE with static compression in patients who underwent TKA demonstrated significantly lower narcotic consumption and increased ambulation distances in the treatment group. The treatment group consumed approximately 170 mg morphine equivalents less than the control group between discharge and the 2-week postoperative visit. In addition, a significant difference was observed in the satisfaction scores in the treatment group.¹¹ Similarly, a meta-analysis by Raynor and colleagues¹² on randomized clinical trials comparing cryotherapy to a placebo group after anterior cruciate ligament reconstruction showed that cryotherapy is associated with significantly lower postoperative pain (P = .02), but demonstrated no difference in postoperative drainage (P = .23) or range of motion (P = .25).

Although multiple studies have been published regarding the efficacy of cryotherapy after knee surgery, very few studies have compared CC to conventional ICE after shoulder surgery. A prospective randomized trial was performed by Singh and colleagues¹³ to compare CC vs no ICE in open and arthroscopic shoulder surgery patients. Both the open and arthroscopic groups receiving CC demonstrated significant reductions in pain frequency and more restful sleep at the 7-day, 14-day, and 21-day intervals compared to the control group. However, they did not compare the commercial unit to ICE. In contrast, a study by Kraeutler and colleagues⁸ randomized 46 patients to receive either CC or ICE in the setting of arthroscopic shoulder surgery. Although no significant difference was observed in morphine equivalent dosage between the 2 groups, the CC group used more pain medication on every postoperative day during the first week after surgery. They found no difference between the 2 groups with regards to narcotic consumption or pain scores. The results of this study mirror those by Kraeutler and colleagues,⁸ demonstrating no difference in pain scores, sleep quality, or narcotic consumption.

Continue to: With rising costs in the US...

The major strengths of this study are the randomized design and multiple data points during the early postoperative period. However, there are several limitations. First, we did not objectively measure compliance of either therapy and relied only on a patient survey. Usage of the commercial CC unit in hours decreased over half between days 3 and 14. This occurred despite training on the application and specific instructions. We believe this reflects “real-world” usage, but it is possible that compliance affected our results. Second, all patients in this study had a single-shot interscalene block. While this is standard at our institution, it is possible that either CC or ICE would have a more significant effect in the absence of an interscalene block. Finally, we did not evaluate final outcomes in this study and therefore cannot determine if the final outcome was different between the 2 groups. Our goal was simply to evaluate the first 2 weeks following surgery, as this is the most painful period following TSA. 

CONCLUSION

There was no difference between CC and ICE in terms of pain control, quality of sleep, patient satisfaction, or narcotic consumption following TSA. CC may offer convenience advantages, but the increased cost associated with this type of unit may not be justified. 

ABSTRACT

Postoperative pain management is an important component of total shoulder arthroplasty (TSA). Continuous cryotherapy (CC) has been proposed as a means of improving postoperative pain control. However, CC represents an increased cost not typically covered by insurance. The purpose of this study is to compare CC to plain ice (ICE) following TSA. The hypothesis was that CC would lead to lower pain scores and decreased narcotic usage during the first 2 weeks postoperatively.

A randomized controlled trial was performed to compare CC to ICE. Forty patients were randomized to receive either CC or ICE following TSA. The rehabilitation and pain control protocols were otherwise standardized. Visual analog scales (VAS) for pain, satisfaction with cold therapy, and quality of sleep were recorded preoperatively and postoperatively at 24 hours, 3 days, 7 days, and 14 days following surgery. Narcotic usage in morphine equivalents was also recorded. 

No significant differences in preoperative pain (5.9 vs 6.8; P = .121), or postoperative pain at 24 hours (4.2 vs 4.3; P = .989), 3 days (4.8 vs 4.7; P = .944), 7 days (2.9 vs 3.3; P = .593) or 14 days (2.5 vs 2.7; P = .742) were observed between the CC and ICE groups. Similarly, no differences in quality of sleep, satisfaction with the cold therapy, or narcotic usage at any time interval were observed between the 2 groups.

No differences in pain control, quality of sleep, patient satisfaction, or narcotic usage were detected between CC and ICE following TSA. CC may offer convenience as an advantage, but the increased cost associated with this type of treatment may not be justified.

The number of total shoulder arthroplasties (TSAs) performed annually is increasing dramatically.¹ At the same time, there has been a push toward decreased length of hospital stay and earlier mobilization following joint replacement surgery. Central to these goals is adequate pain control. Multimodal pain pathways exist, and one of the safest and cheapest methods of pain control is cold therapy, which can be accomplished with continuous cryotherapy (CC) or plain ice (ICE).

Continue to: The mechanism of cryotherapy...

The knee literature contains multiple studies that have examined the benefits of cryotherapy after both arthroscopic and arthroplasty procedures. The clinical benefits on pain have been equivocal with some studies showing improvements using cryotherapy^3,4 and others showing no difference in the treatment group.^5,6

Few studies have examined cryotherapy for the shoulder. Speer and colleagues⁷ demonstrated that postoperative use of CC was effective in reducing recovery time after shoulder surgery. However; they did not provide an ICE comparative group and did not focus specifically on TSA. In another study, Kraeutler and colleagues⁸ examined only arthroscopic shoulder surgery cases in a randomized prospective trial and found no significant different between CC and ICE. They concluded that there did not appear to be a significant benefit in using CC over ICE for arthroscopic shoulder procedures.

The purpose of this study is to prospectively evaluate CC and ICE following TSA. The hypothesis was that CC leads to improved pain control, less narcotic consumption, and improved quality of sleep compared to ICE in the immediate postoperative period following TSA.

MATERIALS AND METHODS

This was a prospective randomized control study of patients undergoing TSA receiving either CC or ICE postoperatively. Institutional Review Board approval was obtained before commencement of the study. Inclusion criteria included patients aged 30 to 90 years old undergoing a primary or revision shoulder arthroplasty procedure between June 2015 and January 2016. Exclusion criteria included hemiarthroplasty procedures.

Continue to: Three patients refused...

Table 1. Summary of Surgical Cases

Abbreviations: CC, continuous cryotherapy; ICE, plain ice; RSA, reverse shoulder arthroplasty; TSA, total shoulder arthroplasty.

All surgeries were performed by Dr. Denard. All patients received a single-shot interscalene nerve block prior to the procedure. A deltopectoral approach was utilized, and the subscapularis was managed with the peel technique.⁹ All patients were admitted to the hospital following surgery. Standard postoperative pain control consisted of as-needed intravenous morphine (1-2 mg every 2 hours, as needed) or an oral narcotic (hydrocodone/acetaminophen 5/325mg, 1-2 every 4 hours, as needed) which was also provided at discharge. However, total narcotic usage was recorded in morphine equivalents to account for substitutions. No non-steroidal anti-inflammatory drugs were allowed until 3 months postoperatively. 

The CC group received treatment from a commercially available cryotherapy unit (Polar Care; Breg). All patients received instructions by a medical professional on how to use the unit. The unit was applied immediately postoperatively and set at a temperature of 45°F to 55°F. Patients were instructed to use the unit continuously during postoperative days 0 to 3. This cryotherapy was administered by a nurse while in the hospital but was left to the responsibility of the patient upon discharge. Patients were instructed to use the unit as needed for pain control during the day and continuously while asleep from days 4 to14. 

The ICE group used standard ice packs postoperatively. The patients were instructed to apply an ice pack for 20 min every 2 hours while awake during days 0 to 3. This therapy was administered by a nurse while in the hospital but left to the responsibility of the patient upon discharge. Patients were instructed to use ice packs as needed for pain control during the day at a maximum of 20 minutes per hour on postoperative days 4 to 14. Compliance by both groups was monitored using a patient survey after hospital discharge. The number of hours that patients used either the CC or ICE per 24-hour period was recorded at 24 hours, 3 days, 7 days, and 14 days. The nursing staff recorded the number of hours of use of either cold modality for each patient prior to hospital discharge. The average length of stay as an inpatient was 1.2 days for the CC group and 1.3 days for the ICE group. 

Visual analog scales (VAS) for pain, satisfaction with the cold therapy, and quality of sleep were recorded preoperatively and postoperatively at 24 hours, 3 days, 7 days, and 14 days following surgery. 

Continue to: The Wilcoxon rank-sum test...

STATISTICAL METHOD

The Wilcoxon rank-sum test was used to assess whether scores changed significantly from the preoperative period to the different postoperative time intervals, as well as to assess the values for pain, quality of sleep, and patient satisfaction. P-values <.05 were considered significant.

RESULTS

No differences were observed in the baseline characteristics between the 2 groups. Both groups showed improvements in pain, quality of sleep, and satisfaction with the cold therapy from the preoperative period to the final follow-up.

The VAS pain scores were not different between the CC and ICE groups preoperatively (5.9 vs 6.8; P = .121) or postoperatively at 24 hours (4.2 vs 4.3; P = .989), 3 days (4.8 vs 4.7; P = .944), 7 days (2.9 vs 3.3; P = .593), or 14 days (2.5 vs 2.7; P = .742).  Both cohorts demonstrated improved overall pain throughout the study period. These findings are summarized in Table 2. 

Table 2. Summary of VAS Pain Scores With Cold Therapy

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice; VAS, visual analog scales.

The number of morphine equivalents of pain medication was not different between the CC and ICE groups postoperatively at 24 hours (43 vs 38 mg; P = .579), 3 days (149 vs 116 mg; P = .201), 7 days (308 vs 228 mg; P = .181), or 14 days (431 vs 348 mg; P = .213). Both groups showed increased narcotic consumption from 24 hours postoperatively until the 2-week follow-up. Narcotic consumption is summarized in Table 3.

Table 3. Summary of Narcotic Consumption in Morphine Equivalents

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice.

VAS for quality of sleep improved in both groups from 24 hours postoperatively until the final follow-up. However, no significant differences in sleep quality were observed between the CC and ICE groups postoperatively at 24 hours (5.1 vs 4.3; P = .382), 3 days (5.1 vs 5.3; P = .601), 7 days (6.0 vs 6.7; P = .319), or 14 days (6.5 vs 7.1; P = .348). The VAS scores for sleep quality are reported in Table 4.

Table 4. Summary of VAS Sleep Quality With Cold Therapy^a

^a0-10 rating with 10 being the highest possible score.

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice; VAS, visual analog scales.

Continue to: Finally, VAS patient satisfaction...

While compliance within each group utilizing the randomly assigned cold modality was similar, the usage by the CC group was consistently higher at all time points recorded. No complications or reoperations were observed in either group.

DISCUSSION

The optimal method for managing postoperative pain from an arthroplasty procedure is controversial. This prospective randomized study attempted to confirm the hypothesis that CC infers better pain control, improves quality of sleep, and decreases narcotic usage compared to ICE in the first 2 weeks after a TSA procedure. The results of this study refuted our hypothesis, demonstrating no significant difference in pain control, satisfaction, narcotic usage, or sleep quality between the CC and ICE cohorts at all time points studied. 

Studies on knees and lower extremities demonstrate equivocal results for the role CC plays in providing improved postoperative pain control. Thienpont¹⁰ evaluated CC in a randomized control trial comparing plain ice packs postoperatively in patients who underwent TKA. The author found no significant difference in VAS for pain or narcotic consumption in morphine equivalents. Thienpont¹⁰ recommended that CC not be used for outpatient knee arthroplasty as it is an additional cost that does not improve pain significantly. Healy and colleagues⁵ reported similar results that CC did not demonstrate a difference in narcotic requirement or pain control compared to plain ice packs, as well as no difference in local postoperative swelling or wound drainage. However, a recently published randomized trial by Su and colleagues¹¹ comparing a cryopneumatic device and ICE with static compression in patients who underwent TKA demonstrated significantly lower narcotic consumption and increased ambulation distances in the treatment group. The treatment group consumed approximately 170 mg morphine equivalents less than the control group between discharge and the 2-week postoperative visit. In addition, a significant difference was observed in the satisfaction scores in the treatment group.¹¹ Similarly, a meta-analysis by Raynor and colleagues¹² on randomized clinical trials comparing cryotherapy to a placebo group after anterior cruciate ligament reconstruction showed that cryotherapy is associated with significantly lower postoperative pain (P = .02), but demonstrated no difference in postoperative drainage (P = .23) or range of motion (P = .25).

Although multiple studies have been published regarding the efficacy of cryotherapy after knee surgery, very few studies have compared CC to conventional ICE after shoulder surgery. A prospective randomized trial was performed by Singh and colleagues¹³ to compare CC vs no ICE in open and arthroscopic shoulder surgery patients. Both the open and arthroscopic groups receiving CC demonstrated significant reductions in pain frequency and more restful sleep at the 7-day, 14-day, and 21-day intervals compared to the control group. However, they did not compare the commercial unit to ICE. In contrast, a study by Kraeutler and colleagues⁸ randomized 46 patients to receive either CC or ICE in the setting of arthroscopic shoulder surgery. Although no significant difference was observed in morphine equivalent dosage between the 2 groups, the CC group used more pain medication on every postoperative day during the first week after surgery. They found no difference between the 2 groups with regards to narcotic consumption or pain scores. The results of this study mirror those by Kraeutler and colleagues,⁸ demonstrating no difference in pain scores, sleep quality, or narcotic consumption.

Continue to: With rising costs in the US...

The major strengths of this study are the randomized design and multiple data points during the early postoperative period. However, there are several limitations. First, we did not objectively measure compliance of either therapy and relied only on a patient survey. Usage of the commercial CC unit in hours decreased over half between days 3 and 14. This occurred despite training on the application and specific instructions. We believe this reflects “real-world” usage, but it is possible that compliance affected our results. Second, all patients in this study had a single-shot interscalene block. While this is standard at our institution, it is possible that either CC or ICE would have a more significant effect in the absence of an interscalene block. Finally, we did not evaluate final outcomes in this study and therefore cannot determine if the final outcome was different between the 2 groups. Our goal was simply to evaluate the first 2 weeks following surgery, as this is the most painful period following TSA. 

CONCLUSION

There was no difference between CC and ICE in terms of pain control, quality of sleep, patient satisfaction, or narcotic consumption following TSA. CC may offer convenience advantages, but the increased cost associated with this type of unit may not be justified. 

A ketogenic diet appears to be effective for children with refractory status epilepticus (RSE) suggests a small trial that included 14 patients.

• A study conducted by the Status Epilepticus Research Group from January 2011 to December 2016 found that 71% of patients with refractory status epilepticus who received a ketogenic diet experienced seizure resolution, verified by EEG findings, within 7 days of starting the regimen.
• 79% of the children with RSE were weaned off enteral infusions of the diet within 14 days.
• Possible adverse effects from the ketogenic diet occurred in 3 of 14 patients, including gastrointestinal paresis and elevated triglyceride levels.
• The regimen produced ketosis within a median of 2 days after it was initiated.
• By 3 months, 4 patients were still seizure free and 3 had fewer seizures.

pediatric Status Epilepticus Research Group (pSERG). Efficacy and safety of ketogenic diet for treatment of pediatric convulsive refractory status epilepticus. Epilepsy Res. 2018;144:1-6.

A ketogenic diet appears to be effective for children with refractory status epilepticus (RSE) suggests a small trial that included 14 patients.

• A study conducted by the Status Epilepticus Research Group from January 2011 to December 2016 found that 71% of patients with refractory status epilepticus who received a ketogenic diet experienced seizure resolution, verified by EEG findings, within 7 days of starting the regimen.
• 79% of the children with RSE were weaned off enteral infusions of the diet within 14 days.
• Possible adverse effects from the ketogenic diet occurred in 3 of 14 patients, including gastrointestinal paresis and elevated triglyceride levels.
• The regimen produced ketosis within a median of 2 days after it was initiated.
• By 3 months, 4 patients were still seizure free and 3 had fewer seizures.

pediatric Status Epilepticus Research Group (pSERG). Efficacy and safety of ketogenic diet for treatment of pediatric convulsive refractory status epilepticus. Epilepsy Res. 2018;144:1-6.

A ketogenic diet appears to be effective for children with refractory status epilepticus (RSE) suggests a small trial that included 14 patients.

• A study conducted by the Status Epilepticus Research Group from January 2011 to December 2016 found that 71% of patients with refractory status epilepticus who received a ketogenic diet experienced seizure resolution, verified by EEG findings, within 7 days of starting the regimen.
• 79% of the children with RSE were weaned off enteral infusions of the diet within 14 days.
• Possible adverse effects from the ketogenic diet occurred in 3 of 14 patients, including gastrointestinal paresis and elevated triglyceride levels.
• The regimen produced ketosis within a median of 2 days after it was initiated.
• By 3 months, 4 patients were still seizure free and 3 had fewer seizures.

pediatric Status Epilepticus Research Group (pSERG). Efficacy and safety of ketogenic diet for treatment of pediatric convulsive refractory status epilepticus. Epilepsy Res. 2018;144:1-6.

The epilepsy associated with focal cortical dysplasia remains a major challenge, but early recognition of the disorder will allow clinicians to consider the possibility of resective surgery, which has been shown to eliminate seizures in some patients.

• A recent review of the medical literature found that most children with focal cortical dysplasia have intractable focal epilepsy.
• The epilepsy observed in patients with focal cortical dysplasia is related to activation of the mTOR pathway and altered receptor neurotransmission.
• The literature review discusses the epidemiology, natural history, and mechanisms that precipitate seizures in children with focal cortical dysplasia.
• Between 25% and 29% of children in a surgical series had focal cortical dysplasia.

Challenges in managing epilepsy associated with focal cortical dysplasia in children. Epilepsy Res. 2018;145:1-17.

The epilepsy associated with focal cortical dysplasia remains a major challenge, but early recognition of the disorder will allow clinicians to consider the possibility of resective surgery, which has been shown to eliminate seizures in some patients.

• A recent review of the medical literature found that most children with focal cortical dysplasia have intractable focal epilepsy.
• The epilepsy observed in patients with focal cortical dysplasia is related to activation of the mTOR pathway and altered receptor neurotransmission.
• The literature review discusses the epidemiology, natural history, and mechanisms that precipitate seizures in children with focal cortical dysplasia.
• Between 25% and 29% of children in a surgical series had focal cortical dysplasia.

Challenges in managing epilepsy associated with focal cortical dysplasia in children. Epilepsy Res. 2018;145:1-17.

The epilepsy associated with focal cortical dysplasia remains a major challenge, but early recognition of the disorder will allow clinicians to consider the possibility of resective surgery, which has been shown to eliminate seizures in some patients.

• A recent review of the medical literature found that most children with focal cortical dysplasia have intractable focal epilepsy.
• The epilepsy observed in patients with focal cortical dysplasia is related to activation of the mTOR pathway and altered receptor neurotransmission.
• The literature review discusses the epidemiology, natural history, and mechanisms that precipitate seizures in children with focal cortical dysplasia.
• Between 25% and 29% of children in a surgical series had focal cortical dysplasia.

Challenges in managing epilepsy associated with focal cortical dysplasia in children. Epilepsy Res. 2018;145:1-17.

Drug therapy for pregnant women with epilepsy has changed markedly in recent years according to analysis of data from the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study.

• MONEAD, an NIH-funded, observational, multicenter study that looked at pregnancy outcomes in mothers and their children, included women ages 14-45 years and up to 20 weeks pregnant.
• Among 351 pregnant women with epilepsy enrolled in the study, 73.8% (259) were on monotherapy and 21.9% (77) on polytherapy; 4% were not taking an antiepileptic drug.
• Lamotrigine was the most popular drug in women on monotherapy, followed by levetiracetam, carbamazepine, zonisamide, oxcarbazepine, and topiramate.
• The most common polypharmacy regimen included  lamotrigine and levetiracetam.

The researchers point out that these percentages only reflect drug usage in US tertiary epilepsy centers and may not indicate usage in community practice.

MONEAD Investigator Group. Changes in antiepileptic drug-prescribing patterns in pregnant women with epilepsy. Epilepsy Behav. 2018;84:10-14.

Drug therapy for pregnant women with epilepsy has changed markedly in recent years according to analysis of data from the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study.

• MONEAD, an NIH-funded, observational, multicenter study that looked at pregnancy outcomes in mothers and their children, included women ages 14-45 years and up to 20 weeks pregnant.
• Among 351 pregnant women with epilepsy enrolled in the study, 73.8% (259) were on monotherapy and 21.9% (77) on polytherapy; 4% were not taking an antiepileptic drug.
• Lamotrigine was the most popular drug in women on monotherapy, followed by levetiracetam, carbamazepine, zonisamide, oxcarbazepine, and topiramate.
• The most common polypharmacy regimen included  lamotrigine and levetiracetam.

The researchers point out that these percentages only reflect drug usage in US tertiary epilepsy centers and may not indicate usage in community practice.

MONEAD Investigator Group. Changes in antiepileptic drug-prescribing patterns in pregnant women with epilepsy. Epilepsy Behav. 2018;84:10-14.

Drug therapy for pregnant women with epilepsy has changed markedly in recent years according to analysis of data from the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study.

• MONEAD, an NIH-funded, observational, multicenter study that looked at pregnancy outcomes in mothers and their children, included women ages 14-45 years and up to 20 weeks pregnant.
• Among 351 pregnant women with epilepsy enrolled in the study, 73.8% (259) were on monotherapy and 21.9% (77) on polytherapy; 4% were not taking an antiepileptic drug.
• Lamotrigine was the most popular drug in women on monotherapy, followed by levetiracetam, carbamazepine, zonisamide, oxcarbazepine, and topiramate.
• The most common polypharmacy regimen included  lamotrigine and levetiracetam.

The researchers point out that these percentages only reflect drug usage in US tertiary epilepsy centers and may not indicate usage in community practice.

MONEAD Investigator Group. Changes in antiepileptic drug-prescribing patterns in pregnant women with epilepsy. Epilepsy Behav. 2018;84:10-14.

SAN DIEGO – Among individuals with a history of injection drug use, more than one-third reported never or sometimes carrying naloxone, while just one in four reported carrying with it them at all times.

Those are key findings from a survey that set out to examine gaps in the naloxone cascade in a sample of people who inject drugs.

“In order to save a life, you have to have the naloxone with you at all times,” lead study author Karin E. Tobin, PhD, said in an interview at the annual meeting of the College on Problems of Drug Dependence.

While emerging research demonstrates the positive impact of opioid overdose education and community naloxone distribution programs to reduce opioid-related overdose deaths, opiate overdose continues to be a major cause of mortality, said Dr. Tobin, who is affiliated with the department of health behavior and society at Johns Hopkins University, Baltimore. “We’ve made a lot of progress in convincing people that naloxone is not addictive, and that it’s not going to cause any harm,” she said. “Now, drug users aren’t afraid to ask for it. Still, we wondered: If everyone knows about naloxone and no one is embarrassed to talk about it, why are people still dying [from opioid overdoses] in Baltimore?”

She and her associates conducted a cross-sectional survey of 353 individuals aged 18 and older in Baltimore who self-reported a lifetime history of injection drug use. The data came from a baseline survey that was conducted as part of a randomized, controlled trial testing the efficacy of a behavioral intervention focused on the Hepatitis C cascade. Individuals were asked to answer questions related to the five steps of the naloxone cascade: awareness (have you ever heard about naloxone?), access (have you ever received naloxone?), training (have you ever been trained to use naloxone?), use (have you ever used naloxone during an opiate overdose?), and possession (how often do you carry naloxone?)

More than half of the survey respondents (65%) were male; mean age was 47 years. For the previous 6 months, more than half of the sample reported the use of crack (64%), heroin (74%), and other injectable drugs (57%), while 90% reported having ever witnessed an overdose – 59% in the prior year alone. Dr. Tobin and her associates found that 90% of respondents had heard about naloxone, 69% had received it, and 60% had been trained to use it. In addition, 37% reported never carrying naloxone, 38% sometimes carried it, 33% said they had used naloxone at some point, and 25% said they always carried it with them.

Doug Brunk/MDedge News

[email protected]

SAN DIEGO – Among individuals with a history of injection drug use, more than one-third reported never or sometimes carrying naloxone, while just one in four reported carrying with it them at all times.

Those are key findings from a survey that set out to examine gaps in the naloxone cascade in a sample of people who inject drugs.

“In order to save a life, you have to have the naloxone with you at all times,” lead study author Karin E. Tobin, PhD, said in an interview at the annual meeting of the College on Problems of Drug Dependence.

While emerging research demonstrates the positive impact of opioid overdose education and community naloxone distribution programs to reduce opioid-related overdose deaths, opiate overdose continues to be a major cause of mortality, said Dr. Tobin, who is affiliated with the department of health behavior and society at Johns Hopkins University, Baltimore. “We’ve made a lot of progress in convincing people that naloxone is not addictive, and that it’s not going to cause any harm,” she said. “Now, drug users aren’t afraid to ask for it. Still, we wondered: If everyone knows about naloxone and no one is embarrassed to talk about it, why are people still dying [from opioid overdoses] in Baltimore?”

She and her associates conducted a cross-sectional survey of 353 individuals aged 18 and older in Baltimore who self-reported a lifetime history of injection drug use. The data came from a baseline survey that was conducted as part of a randomized, controlled trial testing the efficacy of a behavioral intervention focused on the Hepatitis C cascade. Individuals were asked to answer questions related to the five steps of the naloxone cascade: awareness (have you ever heard about naloxone?), access (have you ever received naloxone?), training (have you ever been trained to use naloxone?), use (have you ever used naloxone during an opiate overdose?), and possession (how often do you carry naloxone?)

More than half of the survey respondents (65%) were male; mean age was 47 years. For the previous 6 months, more than half of the sample reported the use of crack (64%), heroin (74%), and other injectable drugs (57%), while 90% reported having ever witnessed an overdose – 59% in the prior year alone. Dr. Tobin and her associates found that 90% of respondents had heard about naloxone, 69% had received it, and 60% had been trained to use it. In addition, 37% reported never carrying naloxone, 38% sometimes carried it, 33% said they had used naloxone at some point, and 25% said they always carried it with them.

Doug Brunk/MDedge News

[email protected]

SAN DIEGO – Among individuals with a history of injection drug use, more than one-third reported never or sometimes carrying naloxone, while just one in four reported carrying with it them at all times.

Those are key findings from a survey that set out to examine gaps in the naloxone cascade in a sample of people who inject drugs.

“In order to save a life, you have to have the naloxone with you at all times,” lead study author Karin E. Tobin, PhD, said in an interview at the annual meeting of the College on Problems of Drug Dependence.

While emerging research demonstrates the positive impact of opioid overdose education and community naloxone distribution programs to reduce opioid-related overdose deaths, opiate overdose continues to be a major cause of mortality, said Dr. Tobin, who is affiliated with the department of health behavior and society at Johns Hopkins University, Baltimore. “We’ve made a lot of progress in convincing people that naloxone is not addictive, and that it’s not going to cause any harm,” she said. “Now, drug users aren’t afraid to ask for it. Still, we wondered: If everyone knows about naloxone and no one is embarrassed to talk about it, why are people still dying [from opioid overdoses] in Baltimore?”

She and her associates conducted a cross-sectional survey of 353 individuals aged 18 and older in Baltimore who self-reported a lifetime history of injection drug use. The data came from a baseline survey that was conducted as part of a randomized, controlled trial testing the efficacy of a behavioral intervention focused on the Hepatitis C cascade. Individuals were asked to answer questions related to the five steps of the naloxone cascade: awareness (have you ever heard about naloxone?), access (have you ever received naloxone?), training (have you ever been trained to use naloxone?), use (have you ever used naloxone during an opiate overdose?), and possession (how often do you carry naloxone?)

More than half of the survey respondents (65%) were male; mean age was 47 years. For the previous 6 months, more than half of the sample reported the use of crack (64%), heroin (74%), and other injectable drugs (57%), while 90% reported having ever witnessed an overdose – 59% in the prior year alone. Dr. Tobin and her associates found that 90% of respondents had heard about naloxone, 69% had received it, and 60% had been trained to use it. In addition, 37% reported never carrying naloxone, 38% sometimes carried it, 33% said they had used naloxone at some point, and 25% said they always carried it with them.

Doug Brunk/MDedge News

[email protected]

SAN DIEGO – Physicians who receive gifts and free meals from opioid manufacturers prescribe more opioids than do their counterparts, a new study suggests.

A sampling of doctors who reported marketing payments or gifts prescribed more of the drugs the following year even as their colleagues prescribed fewer. Researchers also found signs of a dose-effect relationship between more free meals received and more opioid medications prescribed.

The findings, presented at the annual meeting of the College on Problems of Drug Dependence and recently published, do not prove a link between free meals and the massive, deadly opioid epidemic. And the purpose of pharmaceutical marketing, of course, is to persuade physicians to prescribe medications, the researchers noted. The report was published in JAMA Internal Medicine.

Still, in light of the opioid epidemic, “there’s a national effort to reduce overprescribing. Our database suggests that the pharmaceutical industry may be a counterforce,” lead author and pediatrician Scott E. Hadland, MD, MPH, of Boston University, said in an interview.

The findings suggest “it doesn’t take much money to get doctors to potentially prescribe more opioids,” he added.

SOURCE: Hadland SE et al. JAMA Intern Med. 2018 Jun 1;178(6):861-3.

SAN DIEGO – Physicians who receive gifts and free meals from opioid manufacturers prescribe more opioids than do their counterparts, a new study suggests.

A sampling of doctors who reported marketing payments or gifts prescribed more of the drugs the following year even as their colleagues prescribed fewer. Researchers also found signs of a dose-effect relationship between more free meals received and more opioid medications prescribed.

The findings, presented at the annual meeting of the College on Problems of Drug Dependence and recently published, do not prove a link between free meals and the massive, deadly opioid epidemic. And the purpose of pharmaceutical marketing, of course, is to persuade physicians to prescribe medications, the researchers noted. The report was published in JAMA Internal Medicine.

Still, in light of the opioid epidemic, “there’s a national effort to reduce overprescribing. Our database suggests that the pharmaceutical industry may be a counterforce,” lead author and pediatrician Scott E. Hadland, MD, MPH, of Boston University, said in an interview.

The findings suggest “it doesn’t take much money to get doctors to potentially prescribe more opioids,” he added.

SOURCE: Hadland SE et al. JAMA Intern Med. 2018 Jun 1;178(6):861-3.

SAN DIEGO – Physicians who receive gifts and free meals from opioid manufacturers prescribe more opioids than do their counterparts, a new study suggests.

A sampling of doctors who reported marketing payments or gifts prescribed more of the drugs the following year even as their colleagues prescribed fewer. Researchers also found signs of a dose-effect relationship between more free meals received and more opioid medications prescribed.

The findings, presented at the annual meeting of the College on Problems of Drug Dependence and recently published, do not prove a link between free meals and the massive, deadly opioid epidemic. And the purpose of pharmaceutical marketing, of course, is to persuade physicians to prescribe medications, the researchers noted. The report was published in JAMA Internal Medicine.

Still, in light of the opioid epidemic, “there’s a national effort to reduce overprescribing. Our database suggests that the pharmaceutical industry may be a counterforce,” lead author and pediatrician Scott E. Hadland, MD, MPH, of Boston University, said in an interview.

The findings suggest “it doesn’t take much money to get doctors to potentially prescribe more opioids,” he added.

SOURCE: Hadland SE et al. JAMA Intern Med. 2018 Jun 1;178(6):861-3.